ACTRNACTRN12620000008921 : A Phase I, Open-Label, Multiple Ascending Dose Study of the Safety and Tolerability of T3011 in advanced Cutaneous or Subcutaneous Malignancies

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18+Age Over 18

Advanced CancersCancer LocationMulti-Cancer
Trial

Systemic therapy | Sarcoma,SkinBasal cell carcinoma,Cutaneous Squamous Cell Carcinoma (CSCC),Ewing's Sarcoma,Gastrointestinal stromal tumour (GIST),Leiomyosarcoma,Liposarcoma,Melanoma (Skin),Rhabdomyosarcoma,Sarcoma,Soft Tissue Sarcoma,Squamous cell carcinoma ,Synovial Sarcoma

Trial Overview Read MoreRead more

This Phase I trial is trying to understand how safe and tolerable a targeted therapy (T3011) is in people with advanced cancers.
 

This trial is treating patients with advanced cutaneous or subcutaneous cancers.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Phase I, Open-Label, Multiple Ascending Dose Study of the Safety and Tolerability of T3011 in advanced Cutaneous or Subcutaneous Malignancies

Commercial Sponsor

Immvira Pharma Co Ltd

Summary

This is a non-randomised dose escalation study. Participants will receive T3011 at the assigned dose level by intratumoural injection commencing on W1D1, and approximately every 14 days thereafter (ie: W3D1, W5D1 etc) for up to 2 years (unless disease progression, unacceptable toxicity, death or withdrawal of consent). The starting dose of T3011 is 1.0 × 10^6 PFU/mL with the volume injected intratumourally based on tumour size, but not exceeding a total of 4 mls for each visit for all tumours combined. The study uses a 3+3 dose escalation design to evaluate escalating doses of T3011 monotherapy. Three additional doses are planned to be tested (1.0 × 10^7, 5.0 × 10^7, and 1 × 10^8 PFU/ml). At any dose level, if no dose-limiting toxicity (DLT) occurs among the first 3 participants, then escalation to the next dose level may proceed if approved by the Safety Review committee (SRC). If 1 DLT occurs in the first 1 to 3 participants, the dose level will expand to a maximum of 6 participants. If no DLT occurs among the additional participants, then escalation to the next dose level may proceed if approved by the SRC. The non-tolerated dose (NTD) is the dose level at which 2 or more participants experience a DLT during the DLT evaluation period. The maximum tolerated dose (MTD) will be defined as the dose level immediately below the NTD. At least 6 participants will be treated at the MTD before expansion to Part 2 (Dose Expansion) with additional participants treated with a dose selected by the SRC.

Recruiting Hospitals Read MoreRead more

Alfred Hospital, Medical Oncology
Prahran
Ms Eleanor Edwards
El.Edwards@alfred.org.au
03 9076 2297

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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